61 completed, 13 terminated, 12 recruiting, 8 unknown. 106 Phase 2, 19 Phase 1, 9 Phase 3.
Follow Hydroxyurea: new trials by email Literature Review of Hydroxyurea trials Research Report on Hydroxyurea
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Acute Myeloid Leukemia | Phase 2 | Recruiting | Uma Borate | 70 | 2027-01-15 | 2026-11-09 |
| Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia Hydroxycarbamid - R/R AML | Phase 1 / Phase 2 | Not yet recruiting | Christer C Nilsson | 26 | 2026-10-01 | 2026-08-17 |
| Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease Cyclophosphamide 50mg, Abatacept, Alemtuzumab - Sickle Cell Disease | Phase 2 | Recruiting | St. Jude Children's Research Hospital | 45 | 2026-09-10 | 2026-11-12 |
| Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet, Hydroxyurea - Acute Myeloid Leukemia With Gene Mutations | Phase 2 | Recruiting | PETHEMA Foundation | 50 | 2026-06-12 | 2026-09-22 |
| Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study hydroxycarbamide - Sickle Cell Disease, Sickle Cell Anemia in Children | Phase 1 / Phase 2 | Recruiting | Children's Hospital Medical Center, Cincinnati | 250 | 2026-05-13 | 2026-07-16 |
| Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia Pacritinib, Hydroxyurea - Leukemia, Myelomonocytic, Chronic | Phase 2 | Recruiting | Theradex | 66 | 2026-01-01 | 2026-08-18 |
| 177Lu-DOTATATE for Recurrent Meningioma Local standard of Care, 177Lu-DOTATATE - Recurrent Meningioma | Phase 2 | Recruiting | European Organisation for Research and Treatment of Cancer - EORTC | 136 | 2025-03-10 | 2026-06-15 |
| Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease Hydroxycarbamid - Sickle Cell Disease | Phase 2 | Recruiting | Theravia | 50 | 2025-01-21 | 2026-10-01 |
| A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients Hydroxyurea, Hydroxycarbamide, Valproic acid, 6-Mercaptopurine (6-MP) - Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes, Adult | Phase 1 / Phase 2 | Recruiting | Haukeland University Hospital | 48 | 2024-05-23 | 2025-06-29 |
| Combination of Thalidomide and Hydroxyuria in Transfusion Dependent Thalasemmia ADDITION OF THALIDOMIDE AND HYDROXYUREA - Transfusion Dependent Beta Thalassemia | Phase 2 | Completed | Pakistan Blood and Marrow Transplant (PBMT) Group | 100 | 2024-01-01 | 2026-05-05 |
| Realizing Effectiveness Across Continents With Hydroxyurea Hydroxyurea - Sickle Cell Disease, Children | Phase 2 | Active not recruiting | Children's Hospital Medical Center, Cincinnati | 811 | 2023-10-27 | 2026-04-21 |
| A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke Etavopivat, Hydroxyurea - Sickle Cell Disease | Phase 2 | Recruiting | Forma Therapeutics, Inc. | 27 | 2023-06-20 | 2026-09-10 |
| Hydroxyurea and EPO in Sickle Cell Disease Hydroxyurea, Epoetin Alfa-BioSimilar - Anemia, Sickle Cell, Sickle Cell Disease | Phase 1 / Phase 2 | Completed | Julia Xu | 17 | 2023-05-25 | 2026-01-07 |
| Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified, Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified | Phase 2 | Terminated | Mayo Clinic | 3 | 2023-02-20 | 2024-09-19 |
| Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease. Hydroxycarbamide - Sickle Cell Disease | Phase 2 | Completed | Theravia | 33 | 2022-07-08 | 2022-11-23 |
| Addition of JSP191 (C-kit Antibody) to Nonmyeloablative Hematopoietic Cell Transplantation for Sickle Cell Disease and Beta-Thalassemia TBI, Hydroxyurea, briquilimab - Sickle Cell Anemia, Beta Thalassemia | Phase 1 / Phase 2 | Active not recruiting | National Heart, Lung, and Blood Institute (NHLBI) | 40 | 2022-05-12 | 2026-03-12 |
| A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study Tadalafil, Hydroxyurea, Placebo - Priapism Due to Sickle Cell Disease | Phase 2 | Completed | Vanderbilt University Medical Center | 64 | 2022-04-01 | 2024-09-20 |
| Long Term Beta Thalassemia Treatment: Findings From The Extension Period thalidomide and hydroxyurea, Thalidomide - Fetal Hemoglobin, Beta-Thalassemia | Phase 2 | Active not recruiting | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | 30 | 2022-04-01 | 2025-05-30 |
| A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis TQ05105 tablets, Hydroxycarbamide tablets - Moderate and High Risk Myelofibrosis | Phase 2 | Completed | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 107 | 2021-11-11 | 2026-06-02 |
| Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study. Thalidomide 100mg, Hydroxyurea - Beta-Thalassemia | Phase 2 | Completed | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | 24 | 2021-09-01 | 2024-03-12 |
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Anemia, Sickle Cell (33) · beta-Thalassemia (11) · HIV Infections (7) · Brain Neoplasms (6) · Head and Neck Neoplasms (6) · Leukemia, Myeloid, Acute (6) · Meningioma (6) · Squamous Cell Carcinoma of Head and Neck (6) · Hemoglobin SC Disease (4) · Hemoglobinopathies (4) · Thalassemia (4) · Esophageal Neoplasms (3) · Glioblastoma (3) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (3) · Muscular Atrophy, Spinal (3)
St. Jude Children's Research Hospital (6) · University of Chicago (6) · Children's Hospital Medical Center, Cincinnati (5) · National Heart, Lung, and Blood Institute (NHLBI) (5) · National Institute of Allergy and Infectious Diseases (NIAID) (4) · Duke University (3) · National Cancer Institute (NCI) (3) · Paul Szabolcs (3) · Theravia (3) · Baylor College of Medicine (2) · Beni-Suef University (2) · Bristol-Myers Squibb (2) · Children's Hospital Karachi (2) · Children's National Research Institute (2) · National Institute of Blood and Marrow Transplant (NIBMT), Pakistan (2)
United States (63) · France (11) · Pakistan (7) · Italy (5) · Nigeria (4) · United Kingdom (4) · Egypt (3) · Germany (3) · Norway (3) · Spain (3) · Uganda (3) · Angola (2) · Brazil (2) · China (2) · Democratic Republic of the Congo (2)
Everett Vokes, MD (4) · Russell Ware, MD, PhD (3) · Ahmed F Mahmoud Hussein, MS.c (2) · Dr Ching H. Wang (2) · Everett E. Vokes, MD (2) · Jeremie Estepp, MD (2) · Paul Szabolcs, MD (2) · Scott Wadler, MD (2) · Vivien Sheehan, MD (2) · Abel Makubi, MMed (1) · Abhishek A. Mangaonkar, M.B.B.S. (1) · Akshay Sharma, MBBS (1)
PMID 35477175, PMID 36240296, PMID 41026975, PMID 41954645, PMID 12074329, PMID 16849759, PMID 17146105, PMID 20830768, PMID 21275961, PMID 21586746, PMID 21938530, PMID 23927461, PMID 26275071, PMID 26428319, PMID 27619954, PMID 27756209, PMID 28850716, PMID 29318647, PMID 29784451, PMID 30481287, PMID 30501550, PMID 32425398, PMID 32634238, PMID 32672489, PMID 32750127, PMID 34323164, PMID 34456732, PMID 35982483, PMID 36637054, PMID 36699430, PMID 36870358, PMID 37345627, PMID 37428866, PMID 37604857, PMID 38268013, PMID 38691679, PMID 38701812, PMID 38842838, PMID 39998298, PMID 39998301, PMID 40048190, PMID 40062628, PMID 40073378, PMID 40774695, PMID 40780831, PMID 41253090, PMID 41871072, PMID 42133908
2008 (1), 2009 (1), 2017 (1), 2018 (1), 3UL1RR025005 (1), N01CM62201 (1), P30CA013330 (1), P30CA014599 (1), P60HL015157 (1), P60HL020985 (1), P60HL028391 (1), R34HL127162 (1), U01HL133883 (1), U10CA031946 (1), U10CA032102 (1)